Directive 98/79 definition

Directive 98/79 means Directive 98/79/EC of the European Parliament and of the Council of 27th October 1998 on in vitro diagnostic medical devices(5);
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Examples of Directive 98/79 in a sentence

  • The Masters Games Sub-Committee will assign heats, age groups and numbers.9) USATF Sanction:Bidder shall obtain a USATF sanction for the Championships and shall have in place General Commercial Liability insurance with an insurance company or companies acceptable to USATF, which shall provide liability coverage with a limit of not less than one million ($1,000,000) dollars per occurrence and ten million ($10,000,000) dollars excess coverage.

  • In order to be compliant with this criterion bidder will be requested to provide one of the following pre-market approval(s) / market clearance(s)/registration(s): A.1. CE mark (EU), (Directive 93/42 EEC or Directive 98/79 EEC), orA.2. Registration No. issued by the Medicines and Medical Devices Agency of the Republic of Moldova.

  • In order to be compliant with this criterion bidder will be requested to provide one of the following pre-market approval(s) / market clearance(s)/registration(s): A.1. CE mark (EU), (Directive 93/42 EEC or Directive 98/79 EEC), orA.2. Registration No. issued by the Medicines and Medical Devices Agency of the Republic of Moldova;(A.3. is deleted) 2.1.2. B.

  • Medical Devices:The EU regulatory framework for medical devices is set out in three Directives: Directive 90/385/EEC on Active Implantable Medical Devices; Directive 93/42/EEC on Medical Devices; and Directive 98/79 /EC on In Vitro Diagnostic MedicalDevices.

  • The new rules replace Med Device Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC) and the In-Vitro Diagnostic Medical Device Directive (98/79/ EC).

  • Data of working documents of IVD MD manufacturers complying with the requirements of the Directive 98/79 EC are certainly considered to be the data proving validation of the method.The laboratory must have complete primary data at its disposal from the measurements carried out during validation experiments and all the primary data of statistical assessments.

  • According to the Directive 98/79 EC, the control materials should be recommended, supplied and described by IVD manufacturer in accordance with ISO 15198: 2004.

  • Directive 98/79/ EC does not contain any rules concerning the distribution of in vitro diagnostic medical devices after their placing on the market or their putting into service.Consequently, the national measure corresponding to Article 2 of the Regulations does not fall under the scope of Directive 98/79/EC.

  • Genetic tests with a medical purpose fall within the definition of IVD medical devices and the regulation of their safety and efficiency when entering the European market currently falls under the scope of Directive 98/79 EC on in vitro diagnostic medical devices (IVD Directive) [72].

Related to Directive 98/79

  • CRD Directive means the Directive (2013/36/EU) of the European Parliament and of the Council on prudential requirements for credit institutions and investment firms dated 26 June 2013 and published in the Official Journal of the European Union on 27 June 2013 (or, as the case may be, any provision of Danish law transposing or implementing such Directive), as amended or replaced from time to time (including, for the avoidance of doubt, the amendments to such Directive resulting from Directive (EU) 2019/878 of the European Parliament and of the Council as regards exempted entities, financial holding companies, mixed financial holding companies, remuneration, supervisory measures and powers and capital conservation measures dated 20 May 2019 and published in the Official Journal of the European Union on 7 June 2019);

  • Waste Framework Directive or “WFD” means Waste Framework Directive 2008/98/EC of the European Parliament and of the Council on waste.

  • Directive means EC Council Directive 2001/23/EC

  • Change Directive means a written order signed by the procurement officer that

  • Solvency II Directive means Directive 2009/138/EC of the European Parliament and of the Council of the European Union of 25 November 2009 on the taking-up and pursuit of the business of insurance and reinsurance (Solvency II);

  • Labor law decision means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of “labor laws”.

  • Environmental, Health or Safety Requirements of Law means all Requirements of Law derived from or relating to foreign, federal, state and local laws or regulations relating to or addressing pollution or protection of the environment, or protection of worker health or safety, including, but not limited to, the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. § 9601 et seq., the Occupational Safety and Health Act of 1970, 29 U.S.C. § 651 et seq., and the Resource Conservation and Recovery Act of 1976, 42 U.S.C. § 6901 et seq., in each case including any amendments thereto, any successor statutes, and any regulations or guidance promulgated thereunder, and any state or local equivalent thereof.

  • UCITS Directive means Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities, as amended;

  • Construction Change Directive means a written order prepared by Owner Parties and signed by Owner directing Contractor to perform a change in the Work prior to agreeing to a change, if any, to the Contract Time, schedule of performance of the Work, Contract Sum, or Contractor’s compensation.

  • Industrial Emissions Directive means DIRECTIVE 2010/75/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 November 2010 on industrial emissions

  • Environmental and Social Management Framework or “ESMF” means the framework included in the EA setting out modalities to be followed in assessing the potential adverse environmental and social impact associated with activities to be implemented under the Project, and the measures to be taken to offset, reduce, or mitigate such adverse impact.

  • Directives means intergovernmental, interagency, or interdepartment administrative or procedural guidelines or instructions which do not affect the rights of, or procedures and practices available to, the public.

  • Environmental, Health, and Safety Requirements means all federal, state, local and foreign statutes, regulations, and ordinances concerning public health and safety, worker health and safety, and pollution or protection of the environment, including without limitation all those relating to the presence, use, production, generation, handling, transportation, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, as such requirements are enacted and in effect on or prior to the Closing Date.

  • Advance directive means a document that contains a health care instruction or a power of attorney for health care.

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • Environmental, Health and Safety Laws means the Comprehensive Environmental Response, Compensation and Liability Act of 1980, the Resource Conservation and Recovery Act of 1976, and the Occupational Safety and Health Act of 1970, each as amended, together with all other laws (including rules, regulations, codes, plans, injunctions, judgments, orders, decrees, rulings, and charges thereunder) of federal, state, local, and foreign governments (and all agencies thereof) concerning pollution or protection of the environment, public health and safety, or employee health and safety, including laws relating to emissions, discharges, releases, or threatened releases of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes into ambient air, surface water, ground water, or lands or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport, or handling of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes.

  • Environmental and Social Management Plan or “ESMP” means a site-specific environmental and social management plan to be prepared in accordance with the parameters laid down in the ESMF and acceptable to the Association, setting forth a set of mitigation, monitoring, and institutional measures to be taken during the implementation and operation of the Project activities to eliminate adverse environmental and social impacts, offset them, or reduce them to acceptable levels, and including the actions needed to implement these measures.

  • Advance health care directive means a power of attorney for health care or a record signed or authorized by a prospective donor containing the prospective donor’s direction concerning a health care decision for the prospective donor.

  • Airworthiness Directive means a requirement for the Inspection, repair or modification of the Engine or any portion thereof as issued by Airworthiness Authorities.

  • CRD IV Directive means Directive 2013/36/EU on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms of the European Parliament and of the Council of 26 June 2013, as the same may be amended or replaced from time to time.

  • Environmental and Safety Requirements means all federal, state, local and foreign statutes, regulations, ordinances and similar provisions having the force or effect of law, all judicial and administrative orders and determinations, all contractual obligations and all common law concerning public health and safety, worker health and safety and pollution or protection of the environment, including all such standards of conduct and bases of obligations relating to the presence, use, production, generation, handling, transport, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, chemical substances or mixtures, pesticides, pollutants, contaminants, toxic chemicals, petroleum products or by-products, asbestos, polychlorinated biphenyls (or PCBs), noise or radiation.

  • Elective Treatment and Procedures means any medical treatment or surgical procedure that is not medically necessary, including any service, treatment, or supplies that are deemed by the federal, or a state or local government authority, or by Us to be research or experimental or that is not recognized as a generally accepted medical practice.

  • Health and Safety Laws means all applicable laws, statutes, regulations, subordinate legislation, bye-laws, common law and other national, international, federal, European Union, state and local laws, judgments, decisions and injunctions of any court or tribunal, and codes of practice and/or guidance notes issued by any applicable government body or authority, public body, trade union, works council, or industry or regional sector authority to the extent that they relate to or apply to the health and safety of any person, including (but not limited to) any such requirements and obligations concerning Covid-19.

  • Public Finance Management Act ’ means the Public Finance Management Act, 1999 (Act No. 1 of 1999);

  • Health and Safety means, in relation to a recipient or a third person, the prevention of death or serious personal injury;

  • Implement of husbandry means a vehicle that is designed for agricultural purposes and